Quality Manual: A quality manual is a document that outlines a pharmaceutical company's quality management system (QMS). It describes the company's organizational structure, procedures, and processes for ensuring that products are manufactured and tested in compliance with regulatory requirements and meet the desired quality standards.
Quality Policies: Quality policies are statements that define a company's commitment to quality and provide guidance on how to achieve it. These policies can cover a wide range of topics, such as product quality, customer satisfaction, regulatory compliance, and continuous improvement.
Specifications: Specifications define the requirements for the quality of raw materials, in-process samples, and finished products. They provide a clear and concise description of the physical, chemical, and biological characteristics of the product, as well as the limits and acceptance criteria for each characteristic.
Log Books: Log books are used to document various activities and events in the pharmaceutical manufacturing process, such as equipment maintenance, calibration, and cleaning. They serve as a record of these activities and provide evidence of compliance with regulatory requirements.
Batch Manufacturing Record (BMR)
Batch Manufacturing Record, also known sometimes as the Batch Production Record, is an approved copy of the MFR for each batch of product being processed, in which data has been filled in during the batch processing. It contains details of the location where production is done, data entries, names of operators making the entries and their signatures with dates, supporting data records (such as cleaning records, equipment calibration details, in-process and final quality control test reports, etc).
Contents of Batch Manufacturing Record
Name of the product.
Date and time of commencement and completion of important stages in the processing.
Name of persons responsible for each critical stage, with initials of operators handling each operation and persons who checked these operations.
Name and quantities of each raw material weighed with the batch number from which the material was drawn (including details of any re-processed materials added).
Major equipment used in the processing.
Results of readings for critical processing parameters.
Details of samples drawn.
In-process testing reports.
The actual yield was obtained at critical phases.
Any deviations from the procedure, with signatures to authorize the deviations; their evaluation and investigation is conducted.
Packaging material and label description, with representative material attached.
Master Formula Record (MFR)
A Master Formula Record is defined as an approved master document, with instructions of how the entire manufacturing process must be performed for each batch size of each product to be manufactured. This document ensures that there is uniformity across batches of the same product.
Contents of Master Formula Record:
Name of product, its strength, and dosage form description.
Name and measure/weight of each active ingredient per dosage unit or unit weight or measure of the drug product.
Statement of total weight or measure of a dosage unit.
List of component names and their weight or measure using the same weight system.
Statement of theoretical weight or measure where necessary in the processing phase.
Statement of theoretical yield with minimum and maximum percentage of yield acceptable beyond which there must be an investigation of the process.
Description of containers, closures, and packaging materials to be used for the drug product packing.
Specimen or copy of each label/labeling material with the date and signature of the authorized person who has approved the labeling.